Diversity in Clinical Trials Is Critical: Here Are 4 Important Reasons Why
Key takeaways:
Non-white racial and ethnic groups lack adequate representation in clinical trials. This is a long-standing issue in clinical research largely due to mistrust and systemic exclusion.
Past and present mistreatment by the medical system has created barriers to participation. Work needs to be done to address this and other barriers.
Potential solutions include making changes in research volunteer recruitment, research staff, and eligibility criteria for participants.
Behind every medication are groups of volunteers that participate in the research process. This rigorous testing process for new treatments is known as clinical trials.
Clinical trial participants should reflect the people who will be taking the medication. Unfortunately, this isn’t always the case. Historically, clinical trials have lacked diversity. They’ve mostly consisted of white men, following the standard set in a 1975 publication.
In 1993, Congress passed the National Institute of Health Revitalization Act. It required that women and people of color be included as subjects in clinical research. This improved participation for women. But it didn’t have the same effect for non-white racial and ethnic groups.
Let’s take a closer look at who is underrepresented in clinical trials. We’ll also dig into why they’re missing and why their presence is important.
Which groups are often underrepresented in clinical trials?
A 2020 report by the FDA showed that almost 60% of clinical trial participants are now women. Yet, enrollment numbers for people of color haven’t improved much. Racial and ethnic diversity in clinical trials is still lacking.
Out of 32,000 participants in clinical trials, 8% were Black or African American and 11% were Hispanic. Black or African American people currently make up 12% of the U.S. population. Hispanic or Latino people make up almost 19% of the population.
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So, why is diverse participation in clinical trials so minimal? We’ll uncover some reasons below.
Why does underrepresentation in clinical trials exist?
Additional resources have been allocated to address diversity in clinical trials since the 1993 NIH Revitalization Act. But underrepresentation is still an issue.
Reasons cited often include:
Lack of awareness about the existence or value of clinical trials
Misinformation
Confusing presentation of important details
Distrust in research and a fear of being a “guinea pig”
Past research misconduct involving unethical research practices
Why is diversity and representation in clinical trials important?
The National Institutes of Health spends over $40 billion on health research for people in the U.S. each year. The goal is to improve the health of all people. So, diversity in clinical trials must remain a priority for the research community. Let’s get into some of the reasons why:
1) It makes medical products safer and more effective
During clinical trials, researchers discover best treatment doses for new medications. They also find how much medication a person can safely take. Side effects and potential interactions are described and evaluated.
The goal is to apply clinical trial results to the general population. But this is difficult if everyone isn’t represented. Researchers could miss important information about risks and benefits of the medical product.
2) It can reduce racial health disparities
Clinical trials provide the basis for standards of care. People who are underserved are also more likely to be underrepresented in research. Medical advances have been made in clinical trials. But people of color haven’t benefited from the research in the same way as others.
People of different backgrounds may respond differently to medications. There’s no biological basis for race, and there are other factors that may contribute to these differences. For example, where a person lives has been shown to have an impact on their health.
It’s important to have a clinical trial population that resembles the real world. This can help to identify disparities. It can also guide healthcare providers on how to improve the quality of care for all people — regardless of their socioeconomic, cultural, or racial background.
3) It makes for a better economy
Clinical research results can influence how healthcare providers treat their patients. It can also improve health outcomes. If people have access to more effective treatments, population health and longevity improve. The happier and healthier the people, the more productive they’ll be. Healthy, productive people make for a better economy.
4) It builds trust in underserved communities
One of the most well-known incidents of research misconduct involved the Tuskegee Experiment. In this study, Black men were exploited for almost 40 years in a secret study. During the study, they were denied access to treatment for an easily curable disease.
After the study was exposed, African American trust in medical research was destroyed. This is an effect that still persists today.
Since that time, trial participants' rights have been protected by certain laws. These laws aim to address systemic problems with research ethics. Special committees like the Institutional Review Board were created to provide oversight of studies. But there’s still work to be done to build trust in Black communities. Increasing diversity and expanding transparency can show that improvements are being made.
What are the best ways to improve diversity in clinical trials?
The research community has been focusing its efforts on improving clinical trial diversity. But it’s essential that we move from good intentions to actionable items that make an impact. Now that we’ve identified some of the barriers, let’s discuss some possible solutions:
Broaden participant eligibility. People need to meet eligibility requirements to take part in a clinical trial. But some criteria (e.g., high blood pressure) may exclude more people from certain racial and ethic groups than others.
Minimize barriers to participation. Some factors make it difficult for people to participate in research. This can include cost, travel, and time away from work. It’s important to address some of these barriers to make it easier to participate.
Improve diversity among clinical research staff. Appointing diverse clinical research staff can help recruitment efforts. Potential volunteers would likely respond better to staff with similar cultural and linguistic backgrounds.
Be transparent about study details. Clinical trial paperwork is sometimes long and difficult to read. People may not always understand what they’re signing up for. It’s important to make sure the study details are transparent and easy to understand.
How can I find and get involved in clinical trials?
There are a variety of ways to get involved in clinical trials. You can start by asking your healthcare provider. They can also let you know if participating in a clinical trial will go well with any of your current treatments.
You can also visit Clinicaltrials.gov. This website contains a database of almost 400,000 clinical trials around the world. You can search by country, treatment name, or condition.
What do I need to know before getting involved in a clinical trial?
If you’re interested in participating in a clinical trial, here’s what you need to know before making a final decision:
Your participation in a clinical trial is completely voluntary. This means you can leave the study at any time if you don’t want to participate anymore. The decision to volunteer is personal and unique to your situation.
Researchers are required to tell you about any potential benefits and risks. Research can be conducted in healthy volunteers or people with a specific condition. It’s important to understand the main purpose of a clinical trial and potential benefits and risks. This can help you decide if it’s the right fit for you.
You must sign an informed consent form and agree to the protocol rules. Volunteers must sign an enrollment form. This is where you agree to follow the rules outlined in the study. It’s important to understand the study’s purpose, protocol, and risks. Take into account potential time, travel, and financial commitments before enrolling.
You can discuss any questions or concerns you have about participating with members of the research team. They can also help clarify anything that seems confusing or isn’t clear.
The U.S. Department of Health and Human Services (HHS) has resources available to learn more about clinical trials. Click here for questions to ask researchers, informational videos, and more.
The bottom line
Expanding diversity in clinical trials has proven to be an uphill battle for the research community. But diversity must become standard practice in order for the full benefit of clinical trials to be realized. After all, what’s the point of developing medications if they don’t benefit the people being treated?
Learn more about any clinical trials related to your health conditions or treatments by talking to your healthcare provider. You can also reach out to clinical trial sites in your community. They can give you additional guidance about whether a clinical trial is the right fit for you.
Why trust our experts?
References
American College of Cardiology. (2020). Racial disparities in hypertension prevalence and management: A crisis control?.
Centers for Disease Control and Prevention. (2020). African American men and high blood pressure control.
Department of Health and Human Services. (2020). About research participation.
Eltorai, A., et al. (2014). Readability of patient education materials on the American Association for Surgery of Trauma website.
Food and Drug Administration. (2018). Informed consent for clinical trials.
Food and Drug Administration. (2019). Institutional Review Boards (IRBs) and protection of human subjects in clinical trials.
Food and Drug Administration. (2020). 2020 Drug trials snapshots summary report
Katz, R. et al. (2007). Willingness of minorities to participate in biomedical studies: confirmatory findings from a follow-up study using the Tuskegee legacy project questionnaire. Journal of the National Medical Association.
National Center for Education Statistics. (2012). Literacy, numeracy, and problem solving in technology-rich environments among U.S. adults: results from the program for the international assessment of adult competencies.
National Institutes of Health Revitalization Act. (1993). 103rd Congress.
Scharff, D. et al. (2010). More than Tuskegee: understanding mistrust about research participation. Journal of Health Care for the Poor and Underserved.
United States Census Bureau (2020). Racial and ethnic diversity in the United States: 2010 census and 2020 census
